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TBS iNsight 3.1.0

by medimaps group SA

TBS iNsight 3.1.0 is a Class II device made by medimaps group SA, listed in FDA GUDID since 28 Feb 2020 (UDI-DI B214OSTBSI3100), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB214OSTBSI3100 UDI-DI Date28 Feb 2020ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
TBS iNsight
Generic name
Bone absorptiometric x-ray system, dual-energy
Model / reference
3.1.0
Primary DI / UDI-DI
B214OSTBSI3100
FDA product code
KGI
GMDN term
Bone absorptiometric x-ray system, dual-energy
Device class
Class II
Regulation number
892.1170
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code KGI (Densitometer, Bone).

Other devices from medimaps group SA

See all devices from medimaps group SA →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)